Regulations

Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for devices that are previously UKCA / CE / CE UKNI marked or for research medical devices. It is governed by a clinical investigation plan with an objective, methodology, and record keeping. Steps involved in Clinical Investigation in UKCA Step 1: Ensure all the information necessary to demonstrate compliance with all the relevant esse...

The different levels of labelling are related to the different levels of packaging. There are 3 levels of packaging which corresponds to the levels of labelling. 3 Levels of Packaging corresponds to Levels of Labelling Primary Packaging (Levels of Labelling) The Primary packaging is the packaging that most closely touches a product and is often referred to as “retail packaging.” Its main goals are to ensure the protection of the product of all the medical devices and inform or...

Many countries demand that medical devices provide textual information in their local language. When different languages are incorporated on a single label or piece of paperwork, this can cause issues with translation, design, and logistics. Users of medical devices that are labelled in a variety of languages may get confused, and delay in locating the proper terminology can occur. As a result, internationally recognised symbols with well specified definitions were established to address these i...

Human translation Human translations produce accurate results because it involves at least one language expert. Translations, with a human touch to them, are precise because of the in-depth knowledge that translators carry Human translations are done by native speakers of a particular language or people certified in language translations . Therefore, it is culturally diverse, nuanced and is of high quality. However, this high-quality product is expensive. Machine translation Machine transla...

The classification of medical devices in the UK market will be based on UK MDR 2002 from 1st January 2021. Medical devices are classified into a particular class based on the level of risk they pose to the patient and according to the intended purpose of use. The medical devices are classified based on the classification rules in Annex IX of Directive 93/42 into one of the following four classes: The medical devices are classified into the above-given classes based on 18 rules men...

Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Mutual Recognition Agreement (MRA) between EU and Switzerland: Possible situations Depending on the terms of MRA, this situation will exempt the manufacturer from EU member states from the Swiss Authorized Representative(AR) requirement. European AR will be accepted as same as Swiss ARs and vice versa. Manufacturers outside the EU and Switzerland will still ne...

Responsibilities of EU Authorised Representative • When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer. • A written mandate/letter designating an authorised representative for a medical device manufacturer is ma...

After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity. UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess. The information needed on the Declaration of Conformity (DoC) is largely the same as what was required on an EU Declaration of Conformity. According to UK’s guidance on UKCA marking, manufacturers are recommended to keep...

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II Device Description and Specification, including variants...